Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Pedicle Screw Case 1 Lid. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-101
In Commercial Distribution

  • 00810005662116 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 Base, Implants. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-201
In Commercial Distribution

  • 00810005662109 ()


  • Surgical instrument/implant rack
No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • Surgical plume evacuation system
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP10X-000
In Commercial Distribution

  • 90841823103553 ()
  • 00841823103550 ()
FO06K-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP05X-000
In Commercial Distribution

  • 90841823103546 ()
  • 00841823103543 ()
FO06K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO05K-SP05X-000
In Commercial Distribution

  • 90841823103539 ()
  • 00841823103536 ()
FO05K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP26X-A00
In Commercial Distribution

  • 00841823103529 ()
FO04K-SP26X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP05X-000
In Commercial Distribution

  • 90841823103515 ()
  • 00841823103512 ()
FO04K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO03K-SP05X-000
In Commercial Distribution

  • 90841823103508 ()
  • 00841823103505 ()
FO03K-SP05X-000

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw
In Commercial Distribution

  • 07290114061407 ()
700-001330-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
Hela, MWP, 96W24F
DIAGNOSTIC HYBRIDS, INC.
72-9624C
In Commercial Distribution

  • 30014613339571 ()
72-9624C

  • Cell culture line IVD
Vero E6, MWP, 96W96F 90% conf
DIAGNOSTIC HYBRIDS, INC.
50-91-9696-90
In Commercial Distribution

  • 30014613339281 ()
50-91-9696-90

  • Cell culture line IVD
Vero E6, MWP, 96W96F
DIAGNOSTIC HYBRIDS, INC.
91-9696
In Commercial Distribution

  • 30014613339274 ()
91-9696

  • Cell culture line IVD
RHMK FLK 225
DIAGNOSTIC HYBRIDS, INC.
49-T225DH
In Commercial Distribution

  • 30014613338307 ()
49-T225DH

  • Cell culture line IVD
CITES RHMK FLK
DIAGNOSTIC HYBRIDS, INC.
C49-T150A
In Commercial Distribution

  • 30014613335627 ()
C49-T150A

  • Cell culture line IVD
CITES KIDNEY RHESUS SV W/C AN
DIAGNOSTIC HYBRIDS, INC.
C49-0102A
In Commercial Distribution

  • 30014613335603 ()
C49-0102A

  • Cell culture line IVD
RHMK P1 FROZEN SUSP. CITES
DIAGNOSTIC HYBRIDS, INC.
C49-00010P
In Commercial Distribution

  • 30014613335597 ()
C49-00010P

  • Cell culture line IVD
MADIN-DARBYCANI KIDNEYW96/60
DIAGNOSTIC HYBRIDS, INC.
99-84121903-9660
In Commercial Distribution

  • 30014613335481 ()
99-84121903-9660

  • Cell culture line IVD
H&V MIX CELLS MWP 96/96 FILL
DIAGNOSTIC HYBRIDS, INC.
98-9696
In Commercial Distribution

  • 30014613335429 ()
98-9696

  • Cell culture line IVD
H&V MIX CELLS MWP W48/24F
DIAGNOSTIC HYBRIDS, INC.
98-4824
In Commercial Distribution

  • 30014613335382 ()
98-4824

  • Cell culture line IVD
H&V-MIX MWP W48/12F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
98-4812C
In Commercial Distribution

  • 30014613335368 ()
98-4812C

  • Cell culture line IVD
H&V MIX CELLS MWP 48/08 FILL
DIAGNOSTIC HYBRIDS, INC.
98-4808DS
In Commercial Distribution

  • 30014613335344 ()
98-4808DS

  • Cell culture line IVD
H&V-MIX MWP W24/18F
DIAGNOSTIC HYBRIDS, INC.
98-2418
In Commercial Distribution

  • 30014613335306 ()
98-2418

  • Cell culture line IVD
H&V-MIX MWP W24/09F
DIAGNOSTIC HYBRIDS, INC.
98-2409
In Commercial Distribution

  • 30014613335283 ()
98-2409

  • Cell culture line IVD
H&V-MIX MWP W24/06F
DIAGNOSTIC HYBRIDS, INC.
98-2406
In Commercial Distribution

  • 30014613335276 ()
98-2406

  • Cell culture line IVD
H&V MIX SV
DIAGNOSTIC HYBRIDS, INC.
98-0101
In Commercial Distribution

  • 30014613335252 ()
98-0101

  • Cell culture line IVD
R-MIX TOO PLATES
DIAGNOSTIC HYBRIDS, INC.
97-4848
In Commercial Distribution

  • 30014613335214 ()
97-4848

  • Cell culture line IVD
R-MIX TOO MWP W48/12F
DIAGNOSTIC HYBRIDS, INC.
97-4812
In Commercial Distribution

  • 30014613335177 ()
97-4812

  • Cell culture line IVD
R-MIX TOO CELLS MWP 48/08 FILL
DIAGNOSTIC HYBRIDS, INC.
97-4808DS
In Commercial Distribution

  • 30014613335160 ()
97-4808DS

  • Cell culture line IVD
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